PMA P020014S022

Device: CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S022
Product code: HHS
Decision date: 2009-04-20
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR CHANGES TO THE PHYSICIAN LABELING PRECAUTION REGARDING MAGNETIC RESONANCE IMAGING OF WOMEN WITH ESSURE MICRO-INSERTS.

Current openFDA PMA Record#

Device: CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S022
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2009-04-20
Decision code: APPR
Date received: 2009-01-02
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE PHYSICIAN LABELING PRECAUTION REGARDING MAGNETIC RESONANCE IMAGING OF WOMEN WITH ESSURE MICRO-INSERTS.